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Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial (WARCEF)

2014年8月29日 更新者：Shunichi Homma、Columbia University

The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is better for preventing death and stroke in patients with poor heart function.

We are now transitioning into the sub-analysis part of the WARCEF patient data.

The study has recently completed data analysis for its Primary Aim. All randomized patients have completed their follow up. All study related procedure as per the protocol has been completed. We are now in the extension phase of the study to obtain more patient data to address further aims of the study. No new procedures are performed and data already in place at the sites will be collected (EKG and echocardiograms).

The aims for this study extension are:

  • To assess progression of cardiac dysfunction over time among heart failure patients
  • To correlate prognosis with cardiac dysfunction

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Warfarin has proven effective in patients with ischemic heart disease, especially in the reduction of stroke, death and re-infarction following myocardial infarction, and in the reduction of stroke in atrial fibrillation. Warfarin is the most promising unstudied intervention in patients with cardiac failure. This randomized, double-blind, multi-center study will define optimal antithrombotic therapy for patients with cardiac (heart) failure and patients with low ejection fraction (EF). EF is the proportion of left ventricular volume emptied during systole. It reliably measures left ventricular systolic function.

With the rapidly increasing numbers of elderly patients with heart failure, this study has important public health implications. The study will determine which of two commonly used treatments Warfarin, an anticoagulant, or aspirin, a drug which affects platelet function is better for preventing death and stroke in patients with low ejection fraction.

研究の種類

介入

入学 (実際)

2305

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Tucson、Arizona、アメリカ
        • University of Arizona Health Sciences Center
      • Tucson、Arizona、アメリカ
        • Southern Arizona Veterans Affairs Medical Center
    • California
      • Santa Clara、California、アメリカ
        • Santa Clara Medical Center
      • West Los Angeles、California、アメリカ
        • West Los Angeles Veterans Affairs Medical Center
    • Colorado
      • Denver、Colorado、アメリカ
        • Denver Health Medical Center
      • Denver、Colorado、アメリカ
        • Denver Veterans Affairs Medical Center
    • District of Columbia
      • Washington、District of Columbia、アメリカ、20037
        • George Washington University
    • Florida
      • Jacksonville、Florida、アメリカ
        • Mayo Clinic Transplant Center
      • Melbourne、Florida、アメリカ
        • Melbourne Internal Medicine Associates
      • Miami、Florida、アメリカ
        • Jackson Memorial Hospital/U. of Miami
      • Miami、Florida、アメリカ
        • Mercy Research Institute
      • Tamarac、Florida、アメリカ
        • Cardiovascular Consultants of South Florida
    • Georgia
      • Atlanta、Georgia、アメリカ
        • Morehouse School of Medicine
      • Gainesville、Georgia、アメリカ
        • Northeast Georgia Heart Center
    • Illinois
      • Chicago、Illinois、アメリカ
        • University of Illinois at Chicago
      • Peoria、Illinois、アメリカ
        • Methodist Heart, Lung and Vascular Institute
    • Kentucky
      • Lexington、Kentucky、アメリカ
        • University of Kentucky
      • Louisville、Kentucky、アメリカ
        • University of Louisville
      • Louisville、Kentucky、アメリカ
        • Louisville Veterans Affairs Medical Center
    • Louisiana
      • Metairie、Louisiana、アメリカ
        • Gulf Regional Research, LLC
      • Shreveport、Louisiana、アメリカ
        • LSU Health Sciences Center
    • Massachusetts
      • Burlington、Massachusetts、アメリカ
        • Lahey Clinic
    • Michigan
      • Detroit、Michigan、アメリカ
        • Veterans Affairs Medical Center
      • Muskegon、Michigan、アメリカ
        • Mercy Health Partners
    • Nevada
      • Reno、Nevada、アメリカ
        • Reno Veterans Affairs Medical Center
    • New Hampshire
      • Concord、New Hampshire、アメリカ
        • Concord Hospital
    • New Jersey
      • New Brunswick、New Jersey、アメリカ
        • UMDNJ - New Brunswick
      • Newark、New Jersey、アメリカ
        • University of Medicine and Dentistry of New Jersey
    • New York
      • Albany、New York、アメリカ
        • Albany Medical College
      • Buffalo、New York、アメリカ
        • Buffalo General Hospital
      • Buffalo、New York、アメリカ
        • Kaleida Health Millard Fillmore Hospital
      • Cedarhurst、New York、アメリカ
        • Five Towns Neuroscience Research
      • New Hyde Park、New York、アメリカ
        • Long Island Jewish Medical Center
      • New York、New York、アメリカ
        • Columbia University Medical Center
      • New York、New York、アメリカ
        • Mount Sinai Medical Center
      • New York、New York、アメリカ、10032
        • Columbia University, New York Presbyterian Hospital PH 3-342
      • Northport、New York、アメリカ
        • Northport Veterans Affairs Medical Center
      • Rochester、New York、アメリカ
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland、Ohio、アメリカ
        • MetroHealth Medical Center
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ
        • Oklahoma City Veterans Affairs Medical Center
    • Pennsylvania
      • Allentown、Pennsylvania、アメリカ
        • LeHigh Valley Hospital
      • Beaver、Pennsylvania、アメリカ
        • Tri-State Medical Group Cardiology
      • Leetsdale、Pennsylvania、アメリカ
        • Sewickley Valley Medical Group, Cardiology
      • Philadelphia、Pennsylvania、アメリカ
        • Hospital of the University of Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ
        • Temple University Hospital
      • Philadelphia、Pennsylvania、アメリカ
        • Albert Einstein Medical Center
      • Philadelphia、Pennsylvania、アメリカ
        • Penn Presbyterian Medical Center
    • South Dakota
      • Fort Meade、South Dakota、アメリカ
        • Black Hills Health Care System
    • Texas
      • Ft. Sam Houston、Texas、アメリカ
        • Brooke Army Medical Center MCHE - MDC Cardiology Service
      • Houston、Texas、アメリカ
        • Michael E. DeBakey Veterans Affairs Medical Center-MEDVAMC
    • Virginia
      • Salem、Virginia、アメリカ
        • Salem VAMC
    • West Virginia
      • Huntington、West Virginia、アメリカ
        • Huntington Veterans Affairs Medical Center
    • Wisconsin
      • Madison、Wisconsin、アメリカ
        • William S. Middleton Memorial Veterans Hospital
  • カナダ
    • Alberta
      • Lethbridge、Alberta、カナダ
        • Center For Neurologic Research
    • Manitoba
      • Winnipeg、Manitoba、カナダ
        • St. Boniface General Hospital
    • New Brunswick
      • Saint John、New Brunswick、カナダ
        • Saint John Regional Hospital
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ
        • QE II Health Sciences Centre
    • Ontario
      • London、Ontario、カナダ
        • London Health Sciences Centre
      • Ottawa、Ontario、カナダ
        • Ottawa Heart Institute
      • Rexdale、Ontario、カナダ
        • Etobicoke Cardiac Research Centre
      • Toronto、Ontario、カナダ
        • St. Michael's Hospital
    • Quebec
      • Montreal、Quebec、カナダ
        • Montreal Heart Institute
      • Montreal、Quebec、カナダ
        • Montreal General Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria

  • Cardiac EF <=35% by radionuclide ventriculography, left ventriculography or quantitive echocardiographic measurement or an echocardiographic Wall Motion Index of <=1.2, within three months of enrollment. The patient's clinical cardiac state at enrollment should be similar to their state at the time of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least three months after an MI, coronary bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.
  • Modified Rankin score <=4.
  • Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
  • Patient is able to follow an outpatient protocol (requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone.
  • Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
  • Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the recent stroke (RS) subgroup.
  • Chronic CHF patients (NYHA I * IV) admitted to the hospital can be randomized prior to discharge if the patient is stable, taking oral medications for 24 hours and ambulatory at the time of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.

Exclusion Criteria

  • The presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.
  • Cyanotic congenital heart disease, Eisenmenger's syndrome.
  • Decompensated heart failure.
  • Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.
  • A contraindication to the use of either warfarin or aspirin, e.g. active peptic ulcer disease, active bleeding diathesis, platelets <100,000*, hematocrit <30, INR >1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST >3x normal*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure > 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine >3.0*. *on most recent test done within 30 days prior to randomization
  • Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
  • Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
  • Comorbid conditions that may limit survival to less than five years.
  • Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual). *A pregnancy test is required for all women of childbearing age.
  • Enrollment in another study that would conflict with WARCEF.
  • Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .
  • Person under 18 years of age.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：aspirin
Aspirin: 325 mg per day
薬：aspirin
325 mg per day
アクティブコンパレータ：warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
薬：Warfarin
INR 2.5-3.0; target INR 2.75

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
時間枠：From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years
The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
時間枠：From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.

The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.

Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.

その他の成果指標

結果測定
メジャーの説明
時間枠
Event Rate Per 100 Patient-years for Ischemic Stroke
時間枠：From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years
Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years
Event Rate Per 100 Patient-years for Intracerebral Hemorrhage
時間枠：From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years
Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years
Event Rate Per 100 Patient-years for Death
時間枠：From date of randomization to date of death component of primary composite outcome, up to 6 years
Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of death component of primary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome
時間枠：From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years
Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.
時間枠：From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years
Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome
時間枠：From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years
Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome
時間枠：From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years
Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome
時間枠：From date of randomization to date of death component of secondary composite outcome, up to 6 years
Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of death component of secondary composite outcome, up to 6 years
Rate Per 100 Patient Years of Major Hemorrhage
時間枠：From date of randomization until end of scheduled follow-up, up to 6 years
Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization until end of scheduled follow-up, up to 6 years
Rate Per 100 Patient-years of Minor Hemorrhage.
時間枠：From date of randomization until the end of scheduled follow-up, up to 6 years
Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
From date of randomization until the end of scheduled follow-up, up to 6 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Columbia University

協力者

National Institute of Neurological Disorders and Stroke (NINDS)

捜査官

  • 主任研究者：Shunichi Homma, M.D.、Principal Cardiologist, Associate Chief, Division of Cardiology, and Director, Echocardiography Laboratories Professor of Medicine
  • 主任研究者：Seamus Thompson, PhD、Statistical PI: Clinical Professor of Biostatistics and Neurology

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2002年10月1日

一次修了 (実際)

2011年8月1日

研究の完了 (実際)

2014年7月1日

試験登録日

最初に提出

2002年7月19日

QC基準を満たした最初の提出物

2002年7月19日

最初の投稿 (見積もり)

2002年7月22日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年9月5日

QC基準を満たした最後の更新が送信されました

2014年8月29日

最終確認日

2014年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (米国 NIH グラント/契約)
  • R01NS39154

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

aspirinの臨床試験

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スポンサー/協力者

場所

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